Associate Manager - Quality Investigations
ROLE OVERVIEW
Pfizer’s Vizag manufacturing site is a critical node in the company’s global supply chain, producing medicines that reach patients worldwide. The Associate Manager – Investigation role sits at the heart of quality assurance and compliance, ensuring that deviations, out-of-specification results, and atypical events are thoroughly examined and resolved. This position directly supports Pfizer’s quality culture, which is science- and risk-based, flexible, and patient-focused. By identifying root causes and implementing robust corrective and preventive actions, the incumbent protects product safety, regulatory standing, and supply continuity. For professionals with a pharma quality background, this is a compelling opportunity to work with a global leader, gain exposure to complex investigations, and develop expertise that is highly valued across the industry. The role offers visibility with cross-functional teams and regulatory inspections.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead and conduct thorough investigations into manufacturing deviations, out-of-specification (OOS) results, and atypical laboratory events, ensuring timely closure and documentation.
- •Perform root cause analysis using structured methodologies such as 5 Why, Fishbone, FMEA, and fault tree analysis to identify true causes and contributing factors.
- •Develop, implement, and track corrective and preventive actions (CAPAs) in collaboration with production, quality control, engineering, and regulatory teams.
- •Author clear, scientifically sound investigation reports that comply with Pfizer policies, cGMP, and global regulatory requirements for audits and inspections.
- •Manage moderately complex projects, prioritize competing tasks, and meet targets within a collaborative team environment.
- •Review and mentor colleagues’ investigation work, ensuring consistency, data integrity, and adherence to established procedures.
- •Apply common AI tools, including generative technologies like ChatGPT or Microsoft Copilot, responsibly to support problem solving and enhance productivity.
- •Periodically review work of other colleagues and may act as a mentor to junior staff, fostering a quality-focused culture.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- MBA/MS or associate’s degree with at least 6 years of experience, or high school diploma with at least 8 years of relevant experience.
- Proven record of problem-solving and decision-making skills in a pharmaceutical manufacturing or quality laboratory setting.
- Strong background in manufacturing, compliance, technology investigations, processes, and quality systems within a regulated environment.
- Ability to work independently and collaboratively in cross-functional teams.
- Effective written and verbal communication skills for report writing and stakeholder updates.
- Computer literate with superior skills in managing Excel spreadsheets and quality management databases such as TrackWise.
- Experience in the pharmaceutical industry, preferably in QA/QC investigations.
PREFERRED QUALIFICATIONS
- •Master’s degree in Pharmacy, Science, or Engineering
- •Lean Six Sigma Green/Black Belt
- •Experience with regulatory inspections (USFDA, EMA, MHRA)
- •Mentoring and coaching junior staff
- •Knowledge of responsible AI practices and risk management
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.
EXPECTED CAREER ROADMAP
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